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| Roche's cancer remedy loses new drug status |
| Joe C Mathew / New Delhi Jan 09, 2010, 00:26 IST |
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Likely test case, with courts yet to rule on patent challenge from generic manufacturers
Swiss drug maker Roche’s lung cancer medicine, Tarceva, which is protected by a patent in India, will now be easily available for generic manufacturers to copy, as it has recently lost its ‘new drug’ status here.
This is the first known instance of a major patented product getting out of the new drug status under the country’s laws. A medicine has a new drug status only during the first four years of its marketing approval in India.
Local drug majors who intend to launch low-cost generic versions of Tarceva can do so simply now, by getting marketing approval from the state-level drug regulators.
Unlike new drugs, whose marketing approvals are given by the apex drug regulator — Drugs Controller General of India — after scrutinising clinical trial data, the state-level approvals are easy, as companies just need to prove that the generic version is therapeutically equivalent to Roche’s medicine.
Typically, dozens of generic versions appear in the market as soon as the state level approvals begin, triggering a price war.
The new drug status loss comes at a time when Roche is already engaged in a patent infringement case with Cipla over Tarceva. While Roche’s medicine costs over Rs 100,000 for a month’s treatment, Cipla has priced its version at one-third of Roche’s price.
Roche has been waging a legal battle with Cipla for withdrawal of generic versions. The Delhi High Court, in an interim order, had refused to grant Roche’s request and allowed Cipla to market the product. Cipla argues that the patent is invalid and has to be revoked.
A senior Roche official said the patient support programme of the company — where medicines are given at much reduced prices on recommendation of an oncologist — brings down the price of Tarceva to that of generic players.
Roche also filed a petition against Natco Pharma — the other Indian company that has launched a low-cost equivalent of Tarceva — in November 2009. Natco has priced its medicine at Rs 25,000 for 30 tablets.
This case will be also taken up by the Delhi HC, in February.
Industry officials see these as test cases for how India’s product patent laws will play out. According to health ministry figures, about 180,000 people are diagnosed with cancer of the lungs and bronchitis every year. Tarceva is prescribed for non-small cell lung cancer.
Dr Reddy’s and Lupin are also known to be keen to launch generic versions of Tarceva in the country.
Tarceva is among the top 10 best-sellers for Roche globally. During the first six months of 2009, it brought in sales of 643 million Swiss francs (Rs 2,800 crore), primarily from Western Europe, Japan and China.
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